The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart FailurePhase 3NCT02251899
A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure
A Phase 3 study testing Disease-Management intervention in people with The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure, run by Health Navigator at 1 site in Sweden.
Trial summary
The aim of this study is to determine whether a nurse-managed telephone-based disease-management intervention can reduce healthcare utilization and improve self-assessed health status in patients with congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure
- What is being tested?
- Disease-Management intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Jun 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ≥1 unplanned inpatient occasion with primary diagnosis of heart failure ( I50) during the last 12 months
- Heart failure grade NYHA II- III
- Accurate heart failure diagnosis
- Living in one of four Swedish counties where the trial is ongoing
Who cannot join
- Deceased
- In a moribund state
- Significant cognitive loss and therefore cannot provide consent
- Psychosis diagnosis
- Severe hearing impairment
- Language difficulties
- Participants in another study
Trial locations and contacts
1 site in 1 country.
Gustaf Edgren contact
Sweden1 site, 1 recruiting
- Recruiting
Stockholms Läns Landsting
Stockholm
Gustaf Edgren, MD PhD, +46708186862, gustaf@pheph.se
About this study
The aim of this study is to determine whether a nurse-managed telephone-based disease-management intervention can reduce healthcare utilization and improve self-assessed health status in patients with congestive heart failure.
- Being tested
- Disease-Management intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease-Management interventionBehavioural
The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person
| Study group | Role | What they receive |
|---|---|---|
| Disease-Management intervention | Experimental | Behavioral: Disease-Management intervention The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person Receives: Behavioral: Disease-Management intervention |
| No Intervention: Control arm | No intervention | Control group not receiving any in |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalizations
Measured: From randomization for up to 2 years
Number of outpatient visits to medical doctor
Measured: From randomization for up to 2 years
Secondary outcomes (3)
Mortality
Measured: From randomization for up to 2 years
Length of hospital stays
Measured: From randomization for up to 2 years
Total health care cost
Measured: From randomization for up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Navigator
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Ostergotland County Council, Sweden, Vastra Gotaland Region, Uppsala County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Gustaf Edgren, Principal investigator, gustaf@pheph.se
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251899
- Sponsor's protocol ID
- HN-AHS-HS-2
- Status last verified
- Mar 2015
- First submitted
- 25 Sep 2014
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Reinius P, Johansson M, Fjellner A, Werr J, Ohlen G, Edgren G. A telephone-based case-management intervention reduces healthcare utilization for frequent emergency department visitors. Eur J Emerg Med. 2013 Oct;20(5):327-34. doi: 10.1097/MEJ.0b013e328358bf5a.
PubMed 22960802
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT02251899
- Acronym / sponsor ID
- HN-AHS-HS-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Health NavigatorUniversity, hospital or other
- Collaborators
- Region Stockholm, Ostergotland County Council, Sweden, Vastra Gotaland Region, Uppsala County Council, Sweden
- Study start
- Jan 2010
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether a nurse-managed telephone-based disease-management intervention can reduce healthcare utilization and improve self-assessed health status in patients with congestive heart failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease-Management intervention | Experimental | Behavioral: Disease-Management interventionBehavioral: Disease-Management intervention The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person |
| No Intervention: Control arm | No intervention | –Control group not receiving any in |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ≥1 unplanned inpatient occasion with primary diagnosis of heart failure ( I50) during the last 12 months
- Heart failure grade NYHA II- III
- Accurate heart failure diagnosis
- Living in one of four Swedish counties where the trial is ongoing
Key exclusion criteria (7 listed)
- Deceased
- In a moribund state
- Significant cognitive loss and therefore cannot provide consent
- Psychosis diagnosis
- Severe hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disease-Management interventionThe participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person | Behavioural | Disease-Management intervention |
Primary outcome
Number of hospitalizations
Time frame: From randomization for up to 2 years
Number of outpatient visits to medical doctor
Time frame: From randomization for up to 2 years
3 secondary outcomes
Mortality
Time frame: From randomization for up to 2 years
Length of hospital stays
Time frame: From randomization for up to 2 years
Total health care cost
Time frame: From randomization for up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- Results publication: PubMed 22960802Reinius P, Johansson M, Fjellner A, Werr J, Ohlen G, Edgren G. A telephone-based case-management intervention reduces healthcare utilization for frequent emergency department visitors. Eur J Emerg Med. 2013 Oct;20(5):327-34. doi: 10.1097/MEJ.0b013e328358bf5a.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustaf Edgren contact
Gustaf Edgren principal investigator
gustaf@pheph.se
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Disease-Management intervention in people with The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure, run by Health Navigator at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustaf Edgren (gustaf@pheph.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospitalizations (time frame: From randomization for up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02251899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.